The human body is made up of trillions of cells that allow it to function, grow, heal and defend itself against hundreds of diseases. Cells of the same type combine to form tissues. Examples of tissues include: connective tissue which helps to support and join together various parts of the body; epithelial tissue which acts as a covering for external and internal body surfaces; muscle tissue which consists of threadlike fibers that can contract to make movement of the body possible; and nervous tissue which carries signals to permit various parts of the body to communicate with each other.
An organ consists of multiple tissues working to perform a particular function. For example, connective, epithelial, muscle and nervous tissues all combine to make up the heart which pumps blood throughout the body. The body's skin, skeletal, muscular, digestive, respiratory, circulatory, urinary, lymphatic, endocrine and nervous systems are all formed from multiple organs that in turn are made up of several different kinds of tissues.
When tissues or organs are damaged or diseased, healthy cells, tissues, or organs from one person may be transplanted to replace the diseased, damaged, or destroyed tissue or organ in another person. Blood transfusion is the most common type of tissue transplanted. After blood products, the most common transplant from person to person (allogeneic) is cadaveric tissue: e.g., bone, tendons, skin, cornea, heart valves and blood vessels. There are more than a million tissue transplants a year; most of these are bone and other musculoskeletal tissues, and in many cases involve some form of a NBI. For instance, bone transplants are commonly used in spinal surgery and the transplanted bone attracts new bone formation and eventually becomes an indistinguishable part of the recipient's bone (osteoinductive). There are various devices that can be used as structural grafts: cages to hold bone grafts or bone substitutes, such as bone graft extenders, demineralized bone matrix (“DBM”), and autogenous bone. NBI, such as titanium or carbon-fiber cages, or resorbable cages or screws, may help to anchor and support the implanted bone, and provide osteoconduction. Cornea transplants improve the vision of the patients whose corneas have become scarred by injury or clouded by age or infection. Skin transplants can be used to temporarily cover areas of the body of burn victims to reduce the risk of infection, prevent the loss of fluids and decrease pain until skin from another part of the patients own body can be utilized for a more permanent transplant. Bone marrow transplants replace the blood-forming tissue within a patient's bones to treat certain kinds of cancer and serious blood disorders.
Tissues are usually isolated and processed for easier use in surgical procedures. For example, whole bones can be used in transplant, or bones can be cut into various shapes or powdered for use in filling voids. Bones from different areas of the body can be combined and processed by proprietary methods into new products designed for unique uses in surgical procedures.
Some tissues can be treated more harshly than others, and the processing methods will determine the likelihood that a tissue product carries an infectious risk. Tissues such as bone that are treated with alcohol, oxidative agent or irradiation have very low or non-existent risks, but some surgeons are reluctant to use these for fear that the functionality of the product has been compromised. Use of antibiotics does not guarantee that bacteria have been totally removed from the graft and have no effect on viruses.
The heart, lungs, kidney and liver are commonly transplanted organs. Such transplant procedures can enhance the quality of life for some patients and restore the health of people who may otherwise die. Some organs like the heart and lungs cannot survive outside the body for more than a couple of hours. Thus, they usually are transplanted quickly from a patient who has been declared brain dead and surviving only by mechanical means in order to perfuse the organs until they can be transplanted to the matched recipient patient in need. Organ registries have been established in many states and countries to identify and prioritize transplant patients in need of an organ. Their position on the registry list will typically determine, when, if ever, they can qualify for a transplant. Many tissues like bone, corneas and skin, however, can be held for longer periods outside the human body. Such tissues can be stored for future transplantation or implantation in refrigerators or freezers at independent tissue banks or tissue processors, and subsequently distributed to storage units within hospitals.
Infection from contaminated grafts is the greatest risk from transplantation. Tissue and organ transplantations have been associated with risk from HIV, hepatitis, bacterial infections, prion associated diseases such as Creutzfeldt-Jakob Disease (“CJD”), rabies, fungus infections, West Nile virus, leucocytic choriomeningitis, as well as many others. Any transplant operation carries the risk of rejection by the body's immune system or infection. Surgeons try to prevent rejection by choosing a donor with the same blood type as the recipient patient. Matching HLA antigens between the donor and recipient may also be important for kidney and bone marrow transplants. Immuno-suppressive drugs like azathioprine, prednisone and cyclosporine are also commonly given to the transplant patient to help prevent tissue or organ rejection. Because such immuno-suppressive drugs act to reduce immune activity within the patient, they may also hinder the body's ability to defend itself against infections.
Improper handling of the cells, tissues or organs prior to their use in the transplant operation can adversely impact their functionality once implanted in the patient, or greatly increase the likelihood of an infection or other adverse reaction by the patient. For example, the TM may be stored at the incorrect temperature or outside a sterile environment. The packaging surrounding the TM may become perforated. Prior to surgery, TM may be improperly reconstituted. Blood and tissue banks are typically better than surgical units in hospitals at establishing some procedures for storing cells, tissues; however, once these materials leave their facilities, the safety system can deteriorate rapidly. Hospitals rarely have established policies and procedures for receiving, handling, storing and reconstituting tissues before their use in surgery. Instead, they allow a great deal of individual discretion to the hospital physicians and nurses for these critical activities. Consequently, standards and procedures can differ greatly across the hospital staff to the potential detriment of the patient.
Many hospitals perform no qualification of the donor sources of tissue that they use in surgical procedures. To the extent that the hospitals institute any certification process for their tissue suppliers, the process tends to be directed to issues of price and delivery schedule, instead of whether the supplier is properly registered, licensed, and compliant with prevailing industry safety standards. It is as if tissue is just another form of paper clips that need to be stocked in the hospital's inventory. Suppliers of tissue have even been known on occasion to bring these critical tissues in their car trunks to the hospital operating room without monitoring storage conditions.
While hospital surgical departments may possess refrigeration units for storing tissue, their staffs frequently do not know how to monitor and control the equipment. Moreover, few surgical units possess the necessary training to reconstitute tissue. The blood bank and surgical units within the hospital may possess individual staff members with knowledge but they are outside of each other's control.
All of these problems can lead to adverse reactions, including serious infections, illnesses and even death for the transplant patient. For example, a healthy, 23-year-old Minnesota student underwent a routine, elective knee surgery in 2004 in which cartilage sourced from a cadaver via a reputable tissue bank was used by the surgeon to repair the knee. Unbeknownst to the surgeon, the corpse sat unrefrigerated for 19 hours, and had been rejected by two other tissue banks. The cartilage also had not been adequately treated to kill bacteria. The student died four days after the surgery from a raging infection.
In another reported case, a California man died in 2006 from the effects of a fungus-infested heart valve that had been recently implanted. Indeed, the United States Food and Drug Administration reports that 207 deaths occur each year from fungus-contaminated heart valves alone.
When such an incident occurs, good medical practice and public health policy requires an immediate investigation of the patient's condition to determine whether the infection, illness or death was caused by the tissue, organ, NBI, or surgical procedure, as opposed to an independent condition in the patient. If the surgical procedure was faulty, then the transplant procedure needs to be traced back to the surgeons and nurses involved, the operating room environment, and the equipment involved to reduce the likelihood of a repeat event. If it was traced back to a NBI malfunction or manufacturing defect, then it needs to be traced back to the supplier. If the TM was the cause, then it needs to be traced back to the donor or supplier so that other TM from the same source is immediately removed from inventory and other patients who are transplant recipients of similar TM from the same supplier or donor can be warned and provided appropriate medical care and counseling. Yet, such a tracing process is frequently impossible because many hospitals fail to log in the TM and NBI that they receive from suppliers and track their use in surgical procedures. Quality problems in hospitals culminated in 2005 when there was a major recall of tissue products inappropriately released by several tissue banks. Yet, repeated attempts to locate tissue products at hospitals that had not been transplanted failed miserably, thereby resulting in other patients receiving potentially contaminated tissue products. During the same recall, hospital protocols for tracing recipients of the potentially contaminated products were found to be substantially inadequate or entirely absent. Close to one year later, there are recipients yet to be identified who have not received appropriate diagnostic treatments and modalities.
In one incident reported within the industry, organs provided by a donor institution resulted in several cases of hepatitis C in the transplanted patients. Because the hospital failed to notify the tissue bank for 16 months, other infected patients were deprived of treatment while this disease could be treated, resulting in additional deaths. A $32 million damage award resulted from a subsequently filed litigation.
In addition, there have been reported cases of physicians taking diseased tissue from in-hospital patients and transplanting it into unsuspecting, healthy patients. These tissues have not been able to be tracked back to the original source, resulting in the recipient's death.
The transplant industry relies upon “tissue usage information cards” that a hospital is supposed to return to the issuing tissue bank after a surgical procedure is completed. Such cards allow the tissue bank to monitor usage of their tissue and notify everyone who has received similar tissue for recall purposes. However, hospitals only return 50-85% of these cards to the tissue banks.
In the case of adverse reaction investigations, hospitals do not usually define what constitutes an adverse reaction and therefore what should be reported. Instead, the reporting responsibility is left to the physician's discretion. Physicians often resort to a gram stain test or cultures on the tissue prior to surgery. But, such test results can be misleading and grossly inadequate to detect diseased tissues.
There are associated risks with tissue transplantation. There are numerous reports of transplant-transmitted infections, including some that resulted in death. For example, there was a recent article (Morbidity and Mortality Weekly Report 2002 (“MMWR”); 51 (March 15th): 207-210) that reported that on Nov. 7, 2001, a 23-year-old male from St. Cloud, Minnesota had knee surgery using a refrigerated “fresh” femoral condyle. On Nov. 10, 2001, the patient developed knee pain and severe hypotension. On Nov. 11, 2001, the patient died from clostridium sordelli sepsis that came from the tissue transplant. On Nov. 13, 2002, a 17-year-old male in Illinois also received a “fresh” femoral condyle and meniscus from the same donor. On Nov. 14, 2002, the patient developed a fever and septic arthritis. The presumed cause was a clostridia infection. Likewise, usage of antibiotics in patients prior to surgery can mask problems contained in tissues.
Because of these abuses and other safety problems within hospital and tissue bank environments, regulatory and standard setting agents like the Joint Commission for the Accreditation of Health Care Organization (“JCAHO”), American Association of Blood Banking (“AABB”), Food & Drug Administration (“FDA”), and the College of American Pathologists (“CAP”) are currently implementing mandates for the safe handling, storage, use, and tracing of TM. However, these mandates provide no instructions or guidelines to the hospital or tissue bank for how to comply. Therefore, such hospitals and tissue banks are left with regulatory and legal liability for their failure to comply, but no tools to use to comply.
Some instances of tissue tracking are reported in the prior art. Thus, U.S. Published Application No. 2005/0262088 filed by Solis et al. discloses a system for organ procurement and transfer. While this system maintains the security of patient information, it does not address the safety of the organ or organ match for the patient.
U.S. Published Application Nos. 2005/0010437 and 2005/0010449 filed by Abukwedar teaches an organ donation system that permits a person to donate or agree to donate one type of organ in order to be accorded preferential receipt of another organ. This exchange program, however, does nothing for tracking the safe receipt, handling, or use of the organ, or tracing its use after surgery.
U.S. Published Application No. 2005/0285715 filed by Comunale discloses a container with an electronic lock controlled by a computer system for carrying blood samples or organs to a hospital in a secure manner. While this transportation container can prevent theft or contamination of the organ by strangers, it does nothing to prevent unsafe handling, storage, or treatment by the hospital of the organ.
Other prior art systems exist within a diagnostic laboratory, for tracking biological samples. Thus, U.S. Published Application No. 2003/0120633 filed by Torre-Bueno assigns unique bar codes to samples that can be scanned and read during processing of the sample within the lab. U.S. Pat. No. 5,416,029 issued to Miller et al. employs color-coded embedding media and corresponding color-coded slides accompanied by words, numbers, or symbols to identify the biological samples. U.S. Pat. No. 5,842,179 issued to Beavers et al. discloses a cryogenic freezer with a security key pad for receiving and tracking information to identify the location of blood and tissue samples stored within the freezer, and when a capsule has been removed from the freezer. While these types of systems may be useful for keeping track of thousands of biological samples stored within a diagnostic laboratory, they do nothing to ensure the safe handling, storage, and treatment of the sample within the lab.
Other prior art references disclose systems for keeping track of the whereabouts of surgical supplies used during surgery to detect if they have been accidentally left inside the patient after surgery. See, e.g., U.S. Published Application No. 2002/0049650 filed by Reff, and U.S. Pat. No. 6,861,954 issued to Levin. U.S. Published Application No. 2002/0082957 filed by Krassi specifies an inventory control system for chemical reagents used within a clinical or diagnostic lab. Such inventory control tracking systems can detect the location or number of products, but once again, they do not address the proper handling and storage of those products.
A comprehensive system for tracking the appropriate handling, storage and use of tissues throughout the tissue bank's or hospital's chain of custody of the materials would be beneficial. Also advantageous would be a system that reliably enables the tracing back of tissues from patient to supplier after an adverse reaction is detected. For tissue and blood banks and larger healthcare providers, this system would ideally be computerized due to the comparatively large number of TM that need to be processed and handled.
Indeed, computer systems are used within the healthcare industry to store, monitor, and track patient information. The hard drives of such computer systems can store large volumes of data which can be password-protected. National home health agencies, hospitals and medical clinics can afford to employ large computer systems run on “point of care” software that permit the clinician to call upon a file containing the medical chart for a patient from the computer's hard drive, review the patient's initial physical assessment, clinical procedures and medicines administered in the past, and update the file for any new clinical procedures or medicines prescribed. Such computer software systems provided by companies like 3M Corporation, Care Package, and St. Louis Software are readily accessible by different doctors or nurses at the hospital or clinic. However, such point-of-care software systems are necessarily complex because of the large number of patients and clinical staff required to access the information It is not uncommon for such programs to require expensive database platform servers and cost upwards of $100,000.
Other computer software systems are known within the industry for assisting the administration of medical care. For instance, U.S. Application 2004/0186746 filed by Angst on Sep. 23, 2004 discloses a USB flash memory device that permits a user to carry his personal medical records with him and launch it on the hard drive of any computer. The information contained within the flash memory device can be protected via a password or encryption. In this manner, the user has accurate medical records for himself when he visits the doctor, or in case of a medical emergency.
Computerized information devices can also be used to monitor a patient in the field. U.S. Application 2004/0117207 published by Brown on Jun. 17, 2004 teaches a handheld microprocessor device used by a patient to monitor and store, e.g., blood glucose level data. This information can then be transmitted to a doctor at a remote location and downloaded by the doctor onto a computer for storage or to produce medical reports.
Many patients do not actually visit a hospital, medical clinic, or doctor's office for medical care due, e.g., to a loss of mobility or frequency of required care. Thus, the doctor or nurse may visit the patient at her home. In such cases, the medical practitioner is away from his office where the medical records, medical treatises and studies, etc. reside. Therefore, U.S. Patent Application 2004/0249666 published by Napolitano et al. provides a healthcare computerized system that provides medical practitioners with best practice patient disease diagnosis and treatment information. In essence, it enables the medical practitioner to carry a bookcase of medical treatises and published studies with her. The practitioner can use this portable information to diagnose and treat the patient in the field.
U.S. Patent Application 2005/0027567 published by Taha on Feb. 3, 2005 on the other hand discloses a data management system containing a field module used by the medical practitioner to collect data for the patient and communicate it back to a server at the home office for use by a doctor or nurse to tell the field practitioner what steps to take to treat the patient. The patient can also use this field module to communicate with his caregiver back at the medical office. See also U.S. Application 2002/0194029 published by Guan et al. on Dec. 19, 2002, which discloses a medical information management system that permits a medical practitioner to carry a patient's medical records with him in image form in the field, consult medical on-line databases, and communicate remotely with other members of the medical staff.
Computer systems are also widely used for dispensing medicines in hospitals via, e.g., an infusion pump. See U.S. Application 2005/0065817 published by Mihai et al. on Mar. 24, 2005; 2005/0055244 published by Mullan et al. on Mar. 10, 2005; and 2005/0055242 published by Bello et al. on Mar. 10, 2005. Such systems typically track and monitor the patient's symptoms to indicate how the administered drug is affecting the patient.
These information management systems available within the healthcare industry typically focus upon “point of care” for the patient, keeping track of all the clinical data for treatment of that patient. At least one computer system is also available from Owens & Minor within the healthcare industry for tracking TM. However, this system provides essentially the same functionality as conventional paper records systems. It does not permit queries directed to TM data, does not track the healthcare institution's processing and handling of the TM, and provides no mechanism for prompting or enabling the healthcare institution to investigate an adverse reaction occurring in the patient. Likewise, large national blood banks use computerized systems to track their massive inventories of blood samples. Such systems keep track of the blood type of each sample, so that a blood sample is not supplied to a patient with an incompatible blood type. Such systems will also provide advice regarding which blood types are compatible and which ones are not from a safety stand point. However, these blood bank computerized systems represent little more than inventory systems without any functionality for tracking the processing and handling of the blood samples.
Thus, a comprehensive computerized system that permits the tracking of the appropriate handling, processing, storage, and use of tissues throughout the tissue bank's or hospital's chain of custody of the materials would be beneficial, particularly if its built-in functionality prompts staff members of the tissue bank or hospital to record necessary data and properly handle, process, store, and use the tissue or organ product. Such a computerized system would also be advantageous if it provides a search or query functionality that reliably enables the tracing back of tissues from patient to supplier after an adverse reaction is detected, or the tracing forward of the TM or NBI material from supplier to patient or hospital in the event of a product recall that is issued by the supplier or the Food and Drug Administration.